Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONTâ„¢ Passive Fixation Defibrillation Leads.
The RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT passive fixation defibrillation leads.
A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.
Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.
Clinic visits will occur at:
Hypotheses testing in the RELIANCE 4-FRONT passive fixation PMCF Study will use standard statistical methodology as specified more in detail in the protocol.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RELIANCE 4-FRONTâ„¢ Passive Fixation | Other | Single arm, all patients will be implanted with the RELIANCE 4-FRONTâ„¢ Passive Fixation lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELIANCE 4-FRONTâ„¢ Passive Fixation lead implantation | Device | Implantation of transvenous defibrillation lead with passive fixation mechanism. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication Free Rate | Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant. | 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Free Rate | Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant. | 3 months through 15 months post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Pacing Threshold at 0.5 ms Pulse Width | Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Grazia Bongiorni, MD | University Hospital Pisa, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Heart Center | Berlin | 13353 | Germany | |||
| Meir Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RELIANCE 4-FRONTâ„¢ Passive Fixation | Single arm, all patients will be implanted with the RELIANCE 4-FRONTâ„¢ Passive Fixation lead RELIANCE 4-FRONTâ„¢ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RELIANCE 4-FRONTâ„¢ Passive Fixation | Single arm, all patients will be implanted with the RELIANCE 4-FRONTâ„¢ Passive Fixation lead RELIANCE 4-FRONTâ„¢ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complication Free Rate | Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant. | 167 have been enrolled. 165 were included in the analysis because for 2 patients the leads have not been implanted | Posted | Number | 95% Confidence Interval | percentage of patients without event | 3-months |
|
|
3-month follow-up data
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RELIANCE 4-FRONTâ„¢ Passive Fixation | Single arm, all patients will be implanted with the RELIANCE 4-FRONTâ„¢ Passive Fixation lead RELIANCE 4-FRONTâ„¢ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inappropriate tachy therapy - SVT | Cardiac disorders | BSC internal coding | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Not yet classified | General disorders | BSC internal coding | Systematic Assessment |
Sample size is rather small and the power of the study is only 80%
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anneleen Viville | Boston Scientific | 0032479983495 | anneleen.viville@bsci.com |
Not provided
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D014693 | Ventricular Fibrillation |
| D054141 | Ventricular Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 Months Post-Implant |
| Complication Free Rate | Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant | 3 months through 24 months post implant |
| Sensed Amplitude | Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected. | 3 Months Post-Implant |
| Pacing Impedance | Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected. | 3 Months Post-Implant |
| Kfar Saba |
| 44281 |
| Israel |
| Beilinson Medical Center | Petah Tikva | 49100 | Israel |
| Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Fondazione di Ricerca e Cura 'Giovanni Paolo II | Campobasso | Italy |
| Ospedale Alessandro Manzoni | Lecco | 23900 | Italy |
| Clinica Mediterranea | Naples | 80121 | Italy |
| Ospedale Buon Consiglio | Naples | 80123 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56127 | Italy |
| Osp. Civile S. Maria Delle Grazie | Pozzuoli | 80078 | Italy |
| Ospedale San Pietro Fatebenefratelli | Rome | 00189 | Italy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Patient demographic data has been collected during the enrollment visit. No study-specific collection was conducted prior to consent. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Complication Free Rate | Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant. | Subjects were eligible for the secondary endpoint analysis if their date of last follow-up was ≥92 days post-implant procedure. | Posted | Number | 95% Confidence Interval | percentage of patients without events | 3 months through 15 months post implant |
|
|
|
| Other Pre-specified | Pacing Threshold at 0.5 ms Pulse Width | Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms. | 167 have been enrolled. 138 were included in the analysis because we have the lead measurements for those number of patients collected . | Posted | Mean | Standard Deviation | Volt | 3 Months Post-Implant |
|
|
|
| Other Pre-specified | Complication Free Rate | Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant | Posted | Number | 95% Confidence Interval | percentage of patients without events | 3 months through 24 months post implant |
|
|
|
| Other Pre-specified | Sensed Amplitude | Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected. | 167 patients were enrolled. From 141 patients we could collected the sensed amplitude at 3 months | Posted | Mean | Standard Deviation | mVolt | 3 Months Post-Implant |
|
|
|
| Other Pre-specified | Pacing Impedance | Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected. | 167 patients have been enrolled. For 150 patients we were able to collect the 3 month pacing impedance | Posted | Mean | Standard Deviation | Ohm | 3 Months Post-Implant |
|
|
|
| 4 |
| 167 |
| 84 |
| 167 |
| 55 |
| 167 |
| Erosion | Skin and subcutaneous tissue disorders | BSC internal coding | Systematic Assessment |
|
| Infection (> 30 days post-implant) | Infections and infestations | BSC internal coding | Systematic Assessment |
|
| Psychological effect due to device therapy | Psychiatric disorders | BSC internal coding | Systematic Assessment |
|
| Post-surgical wound discomfort | Skin and subcutaneous tissue disorders | BSC internal coding | Systematic Assessment |
|
| Post-surgical infection (<= 30 days post-implant) | Infections and infestations | BSC internal coding | Systematic Assessment |
|
| Chest pain | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Hematoma - Pocket (<=30 days post-implant) | Skin and subcutaneous tissue disorders | BSC internal coding | Systematic Assessment |
|
| Conductor coil fracture - RA | General disorders | BSC internal coding | Systematic Assessment |
|
| Elevated threshold - RV | General disorders | BSC internal coding | Systematic Assessment |
|
| Dislodgment - Unable to capture - LV | General disorders | BSC internal coding | Systematic Assessment |
|
| Pneumothorax - Procedure | Injury, poisoning and procedural complications | BSC internal coding | Systematic Assessment |
|
| Ventricular fibrillation (VF) | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Ventricular tachycardia (VT) | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Other SVT (AVRT, AVNRT, EAT etc.) | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Chest pain - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Dyspnea - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Peripheral edema - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Pulmonary edema - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Heart failure symptoms - Unspecified | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Multiple heart failure symptoms | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Multi-system failure - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Hypotension | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Hypertension | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| RELATED TO ISCHEMIA | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Coronary Artery Disease | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Coronary artery disease | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Peripheral vascular disease | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Mitral regurgitation | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Syncope | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Dizziness | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Chest pain - Ischemic | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Chest pain - Other | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Fatigue | General disorders | BSC internal coding | Systematic Assessment |
|
| Cerebrovascular accident (CVA) | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Pulmonary embolism (PE) | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Intracardiac thrombus | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Hematoma - Unrelated to procedure or device | General disorders | BSC internal coding | Systematic Assessment |
|
| Death | General disorders | BSC internal coding | Systematic Assessment |
|
| Systemic infection | Infections and infestations | BSC internal coding | Systematic Assessment |
|
| Fever | General disorders | BSC internal coding | Systematic Assessment |
|
| Physical trauma | Injury, poisoning and procedural complications | BSC internal coding | Systematic Assessment |
|
| Abnormal laboratory values | Blood and lymphatic system disorders | BSC internal coding | Systematic Assessment |
|
| Hematological | Blood and lymphatic system disorders | BSC internal coding | Systematic Assessment |
|
| Neurological | Nervous system disorders | BSC internal coding | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | BSC internal coding | Systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | BSC internal coding | Systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | BSC internal coding | Systematic Assessment |
|
| Renal | Renal and urinary disorders | BSC internal coding | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | BSC internal coding | Systematic Assessment |
|
| Integumentary | Skin and subcutaneous tissue disorders | BSC internal coding | Systematic Assessment |
|
| Head, eyes, ears, nose, throat (HEENT) | General disorders | BSC internal coding | Systematic Assessment |
|
| Endocrine | Endocrine disorders | BSC internal coding | Systematic Assessment |
|
| Multi-system failure | General disorders | BSC internal coding | Systematic Assessment |
|
| sleep apnea | Respiratory, thoracic and mediastinal disorders | BSC internal coding | Systematic Assessment |
|
| Inappropriate tachy therapy - SVT | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Inappropriate tachy therapy - Other | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Post-surgical wound discomfort | Surgical and medical procedures | BSC internal coding | Systematic Assessment |
|
| Inadvertent VT/VF | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Hematoma - Pocket (<=30 days post-implant) | Injury, poisoning and procedural complications | BSC internal coding | Systematic Assessment |
|
| Elevated threshold - RA | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Elevated threshold - RV | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Coronary venous dissection | Vascular disorders | BSC internal coding | Systematic Assessment |
|
| Ventricular fibrillation (VF) | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Ventricular tachycardia (VT) | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Atrial fibrillation (AF) | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Other SVT (AVRT, AVNRT, EAT etc.) | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Syncope - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Chest pain - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Dyspnea - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Multiple heart failure symptoms | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Hypertension - Heart failure | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Chest pain - Ischemic | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Chest pain - Other | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Palpitations | Cardiac disorders | BSC internal coding | Systematic Assessment |
|
| Fatigue | General disorders | BSC internal coding | Systematic Assessment |
|
| Hemorrhage | Surgical and medical procedures | BSC internal coding | Systematic Assessment |
|
| Physical trauma | General disorders | BSC internal coding | Systematic Assessment |
|
| Hematological | Blood and lymphatic system disorders | BSC internal coding | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | BSC internal coding | Systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | BSC internal coding | Systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | BSC internal coding | Systematic Assessment |
|
| Renal | Renal and urinary disorders | BSC internal coding | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | BSC internal coding | Systematic Assessment |
|
| Psychological | Psychiatric disorders | BSC internal coding | Systematic Assessment |
|
| Integumentary | Skin and subcutaneous tissue disorders | BSC internal coding | Systematic Assessment |
|
| Head, eyes, ears, nose, throat (HEENT) | General disorders | BSC internal coding | Systematic Assessment |
|
| Endocrine | Endocrine disorders | BSC internal coding | Systematic Assessment |
|
| Cancer | General disorders | BSC internal coding | Systematic Assessment |
|
| medication side effect | General disorders | BSC internal coding | Systematic Assessment |
|
| pain in device pocket | Skin and subcutaneous tissue disorders | BSC internal coding | Systematic Assessment |
|
Not provided
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |